Kornimate/medical-research-clean huggingface dataset:
reflexion pet/ct imaging performance in patients with various malignancies

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial examines reflexion medical radiotherapy system (rmrs) imaging to the standard of care (soc) fludeoxyglucose f-18 (\[18f\]-fdg)- positron emission tomography (pet)-computed tomography (ct) imaging in patients with various cancers (malignancies). pet is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, \[18f\]-fdg. because some cancers take up \[18f\]-fdg, cancer cells can be seen with pet. ct utilizes x-rays that traverse body from the outside. ct images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. the reflexion system is designed to facilitate delivery of biology-guided radiotherapy (bgrt). the rmrs uses pet emissions to guide radiotherapy delivery in real-time and has been studied for use with fdg (which is an agent used in standard pet-ct scans that targets glucose). information gathered from this study may help researchers to improve pet-ct imaging on the reflexion system. this information will be used in the future to improve planning and delivery of radiotherapy that will target (in real time) the signal released from the \[18f\]-fdg-pet-ct tracer. comparing the imaging from the standard of care \[18f\]-fdg-pet-ct with the \[18f\]-fdg imaging from rmrs may help improve the quality of the imaging captured and determine if imaging can be done on the rmrs at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for cancer.

primary objective: i. to assess imaging performance of the \[18f\]-fdg pet-ct subsystem on the x1 rmrs to detect lesions (primary and metastatic) in patients with various types of malignancies. secondary objective: i. to determine the feasibility of generating a bgrt plan using x1 rmrs-acquired \[18f\]-fdg pet data derived from the imaging-only session at the studied dose level. outline: patients receive \[18f\]-fdg injection and undergo soc \[18f\]-fdg pet-ct on study. patients with at least one pet avid lesion then undergo x1 rmrs pet-ct imaging-only session on study.

Eligibility criteria:
inclusion criteria: * documented informed consent of the participant and/or legally authorized representative * age: \>= 21 years * patients with malignancies (abdominal/pelvic/thoracic/head and neck/breast tumors) undergoing soc \[18f\]-fdg pet-ct for diagnostic and/or radiotherapy planning purposes * patients should be scheduled for \[18f\]-fdg pet-ct prior to study entry exclusion criteria: * known psychiatric or substance abuse disorder that would interfere with conduct of the study * patient weight exceeding the weight limit (450 pounds) outlined per x1 rmrs specifications sheet * lung parenchymal and bone tumors will be excluded as their imaging characteristics were evaluated in a previous study
a study of ly3537031 in overweight, obese, and healthy participants

Conditions: Healthy; Obesity

Summary: this is a 3-part study that includes a part a, part b, and part c. part a will study the safety and tolerability of the study drug known as ly3537031 in participants who are overweight and obese. part b and part c will study the safety and tolerability of ly3537031 in healthy participants. part c will contain only japanese and chinese healthy participants. blood tests will be performed to check how much ly3537031 gets into the bloodstream and how long it takes the body to eliminate it. body weight will be measured. the study will last approximately 48 weeks excluding a screening period.


Eligibility criteria:
inclusion criteria: * have a bmi within the range of: * part a: 27.0 to 45.0 kilogram per square meter (kg/m²) * part b: 22.0 to 26.9 kg/m² * parts b and c: weigh 60 kg (80 lbs) or more at screening * have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening * have a thyroid stimulating hormone (tsh) value within normal local laboratory ranges. exclusion criteria: * have undergone any form of bariatric surgery * participants who are lactating * have taken medications that promote weight loss within 90 days before screening * have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/l) (35 picograms per milliliter (pg/ml))
intravoxel incoherent motion (ivim) magnetic resonance imaging in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: intravoxel incoherent motion (ivim) is technique based on diffusion-weighted imaging (dwi). in this study, the investigators evaluate the use of ivim in patients with multiple sclerosis.

intravoxel incoherent motion (ivim) is technique based on diffusion-weighted imaging (dwi), it is achieved through an mri acquisition with multiple small b value to extract perfusion data. it has been shown to be a promising technique in evaluation of many brain conditions. this study seeks to assess intravoxel incoherent motion (ivim) parameters in characterizing plaques and specific tissues in multiple sclerosis.

Eligibility criteria:
inclusion criteria: 1. patients who are 18 years or older. 2. relapsing-remitting ms diagnosed as per macdonald criteria exclusion criteria: 1. contraindication to mri. for example, metal implantation in the body, claustrophobia and pregnancy. 2. patients who are unable to tolerate the scans without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.
comparison of faucs vs. misgav ladach

Conditions: Pain, Postoperative; Ambulation Difficulty

Summary: this study aims to compare two techniques for performing a cesarean delivery: misgav ladach versus french ambulatory cesarean section (faucs). the second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. such comparison has not been done so far, and this study will examined if indeed the faucs techniques offers any advantages.

the faucs technique for performing a cesarean section has been described by a french group several years ago, and is claimed to reduce postoperative pain and increase ambulation. with this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. the left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. the uterine incision in performed as usual. due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. no urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. the patient is encouraged to get out of bed 3-4 hours post surgery. this technique for performing a cesarean section will be compared with the traditional (misgav ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Eligibility criteria:
inclusion criteria: * patients scheduled for a cesarean section * term pregnancy: 37-42 weeks * singleton pregnancy * age 18 and above * patients capable of signing an informed consent exclusion criteria: * multiple pregnancy * emergency cesarean * previous 3 cesareans and above * placenta accreta * uterine myomas in the lower segment * fetal growth restriction * fetal anemia * preeclampsia * women scheduled for general anesthesia

Keywords: cesarean
pkudos: phenylketonuria (pku) demographic, outcomes, and safety registry

Conditions: Phenylketonuria; Hyperphenylalaninaemia

Summary: the objective of this study is to evaluate the safety of long-term treatment with kuvan.

the pkudos program is a voluntary, multicenter, strictly observational program for patients with pku who have either received kuvan therapy, or currently receive kuvan, or intend to begin receiving kuvan therapy within 90 days of entering the registry.

Eligibility criteria:
pkudos registry inclusion criteria: * patient has confirmed diagnosis of pku with hyperphenylalaninemia documented by a phenylalanine level of greater than or equal to 360 umol/l (6 mg/dl) * patient has previously received kuvan * patient is currently receiving kuvan * patient intends to receive kuvan therapy within 90 days of enrollment into the registry * the patient is being followed at a pkudos participating center * willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian * willing to provide personal health information exclusion criteria: * patients are not eligible to participate in pkudos if they are participating in a biomarin-sponsored clinical study of kuvan * patients not previously treated with kuvan and patients that are unwilling to begin kuvan therapy within 90 days of entry into the registry pku moms subregistry inclusion criteria: * willing to enroll in (or are already enrolled in) pkudos * agree to follow the standard of care for pregnant women with pku in the united states (nih, 200, nih consensus statement) * agree to be followed by a hospital or pku clinic offering the standard of care for maternal pku * are within 10 weeks of their last menstrual period exclusion criteria: * patients who have not adhered to the standard of care for pregnant women with pku in the united states are not eligible to participate in pku moms

Keywords: phenylketonuria hyperphenylalaninemia pku phenylalanine
the effects of dha on periodontitis

Conditions: Periodontitis; Gingivitis; Inflammation

Summary: the purpose of this study is to determine whether docosahexaenoic acid (dha) is effective in the treatment of periodontitis in adults.

1. the primary aim of this study is to investigate the effect of docosahexaenoic acid (dha; 2 gm/day) plus low dose aspirin (asa 81 mg/day)compared to asa alone on periodontitis over three months. our hypothesis is that dha plus asa will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to asa alone. 2. assess the effect of dha and asa exposure on markers of local inflammation, including gingival crevicular fluid (gcf) crp, il-1 beta and il-6 three months after exposure to dha plus asa compared to asa alone. 3. evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to dha and asa compared to asa alone. our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state. 4. assess the effect of dha and asa exposure on markers of systemic inflammation, including serum c-reactive protein (crp), interleukin-6 (il-6) and vascular adhesion molecule (vcam) compared to asa. our hypothesis is that there will be a decrease in serum crp, il-6 and vcam three months after exposure to dha plus asa compared to asa alone. 5. assess the effect of dha and asa exposure on markers of systemic bone turnover, including urine n-terminal telopeptide (ntx) compared to asa. our hypothesis is that there will be a decrease in urine ntx three months after exposure to dha plus asa compared to asa alone.

Eligibility criteria:
inclusion criteria: * age \>40 years * \>20 natural teeth (excluding third molars) * no orthodontic appliances * periodontitis defined as \>4 teeth with pocket probing depths \>5 mm exclusion criteria: * pregnancy * diabetes * severe chronic diseases * gastrointestinal bleeding * uncontrolled chronic diseases * autoimmune disorders * conditions requiring antibiotic prophylaxis * warfarin * clopidogrel * antimicrobial therapy within 30 days * chronic use of non-steroidal anti-inflammatory drugs (other than aspirin) * omega-3 fatty acid use within 6 months * loose teeth * painful teeth * periodontal abscess * pocket depths \>10 mm in \>1 tooth * periodontal therapy within the past two years * allergy to aspirin * allergy to fish oil * allergy to corn oil * allergy to soybean oil

Keywords: docosahexaenoic acid dha periodontitis gingivitis omega-3 fatty acid fish oil
yoga for treating people at risk for diabetes or with both hiv and depression

Conditions: HIV Infections; Diabetes; Depression

Summary: the purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. this study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both hiv and depression.

in recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. this study will comprise two substudies that will evaluate the effects of yoga in two distinct populations. participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both hiv and depression. all participants will practice yoga 3 to 6 days per week for 3 months. blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. all study participants will be assessed at entry and at 3 and 6 months.

Eligibility criteria:
inclusion criteria for study 1 participants: * meet certain laboratory requirements inclusion criteria for study 2 participants: * hiv infected * able to walk at least 50% of the time inclusion criteria for all participants: * written informed consent of parent/guardian, if applicable exclusion criteria for study 2 participants: * require antiretroviral therapy

Keywords: yoga meditation
motor control training in individuals with subacromial pain syndrome

Conditions: Shoulder Pain

Summary: the porpusose of this study is to evaluate the repercussions of a motor control exercise protocol in patients with subacromial pain syndrome without indication of surgical repair.

methods: this is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. all volunteers will undergo pre-assessment (av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. after the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (ge - conventional exercises with elastic band) and motor control (gcm - motor control training). the intervention protocol will last eight weeks. after four weeks, the second assessment (av2), similar to av1, will be performed and the global change perception questionnaire will be added. at the end of the intervention protocol, the third evaluation (av3), similar to av2, will be performed. a follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to av3. the project will be submitted to the research ethics committee of the federal university of rio grande do norte through the national interface "plataforma brasil". the study will also be registered on the international clinical trial platform, clinicaltrials.gov. the study will only begin after approval of the ethics and research committee. all volunteers should read and sign the terms of free and informed consent.

Eligibility criteria:
inclusion criteria: * present subacromial pain with a score greater than or equal to 2 (visual analog scale) for more than 2 months; * positive neer test; * positive hawkins test; * positive jobe test (pain); * positive patte test (pain); * involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by magnetic nuclear resonance (mri) examination. exclusion criteria: * intense pain during the evaluations; * fail to properly perform the evaluation procedures; * two consecutive or five alternating absences during the training protocol.

Keywords: shoulder rehabilitation electromyography posture analysis
neuropathic pain database

Conditions: Neuropathic Pain

Summary: to establish the infrastructure for a national neuropathic pain database. to determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.

the database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on methods, measurement and pain assessment in clinical trials (immpact)(turk et al.,pain 2003;106:337-345) the immpact panel determined that patients should be evaluated according to six core domains as follows: pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition. the database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (gilron i et al., cmaj 2006; 175: 265-275; attal n et al., european journal of neurology 2006; 13: 1153-1169)

Eligibility criteria:
inclusion criteria: * primarily neuropathic pain * able to give informed consent * estimated life expectancy of 2 years exclusion criteria: * not primarily neuropathic pain * declined participation- too much traveling * declined participation- unknown * declined participation- other, specify * considered unreliable- personality disorder * considered unreliable- cognitive impairment * considered unreliable- substance abuse * considered unreliable- other * language barrier * exceeded quarterly quota * presentation with progressive or recurrent cancer, fibromyalgia, perineal pain of unknown etiology * other, specify

Keywords: neuropathic pain database prospective national
observational study of blood pressure measurements and continuous dialysis

Conditions: Kidney Failure; Respiratory Failure; Critical Illness; Shock

Summary: dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. control of fluid removal is much more difficult. this study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis. we hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.


Eligibility criteria:
inclusion criteria: * age \> 17 years old * cvvhd renal replacement therapy * indwelling arterial line exclusion criteria: * age \< 18 years old * pregnancy * temperature \< 34°c * severe mechanical ventilator dyssynchrony * cardiac arrhythmias precluding automated ppv measurement by icu monitors * non-pulsatile cardiac flow * open thoracic cavity

Keywords: pulse pressure variation continuous venovenous hemodialysis volume status critical care
end-tidal oxygen can reliably predict the arterial partial pressure of oxygen among emergency department patients

Conditions: Intubation Complication

Summary: recent studies have shown that end tidal oxygen (eto2) monitoring can be useful to determine the adequacy of preoxygenation. no study has assessed the correlation between eto2 values obtained during preoxygenation to predict the pao2 in patients undergoing rsi in the ed. our objective was to determine whether a novel equation using the eto2 at the end of preoxygenation could reliably estimate the partial pressure of arterial oxygen (pao2) in critically-ill ed patients undergoing rsi.

rapid sequence intubation (rsi) is the preferred and most commonly-used method of definitive airway management among critically ill emergency department (ed) patients requiring intubation. adequate preoxygenation is intended to prolong the safe apnoeic period. optimal preoxygenation for ed patient undergoing rsi is best described as a two-part process of denitrogenation of the functional residual capacity (frc) and the formation of an oxygen reservoir within the alveoli. end-tidal o2 (eto2) has been shown to be a reliable surrogate marker for denitrogenation. most of the literature supporting eto2 as an adequate maker of adequate preoxygenation has been conducted in the operating room setting. this population varies significantly from the population requiring endotracheal intubation in the ed. our study aim was to show that the use of a gas analyzer measuring the fraction of inspired oxygen (fio2) and eto2 during the preoxygenation phase of ed rsi can reliably predict the minimal pao2 at the end of the ed preoxygenation period.

Eligibility criteria:
inclusion criteria: * all patients undergoing rapid sequence intubation. exclusion criteria: * patients presenting to the emergency department in cardiac or traumatic arrest * patients who received bi-level positive airway pressure (bipap) as the primary delivery of preoxygenation.

Keywords: end tidal oxygen preoxygenation arterial oxygen
controlled study of ono-8025 (krp-197) in patients with overactive bladder in japan

Conditions: Overactive Bladder

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-8025 (krp-197) in patients with overactive bladder.


Eligibility criteria:
inclusion criteria: 1. patients who are 20 years old or over with overactive bladder 2. total number of urinary incontinence episodes per week is 5 or over 3. mean number of micturition per day is 8 or over 4. mean number of urinary urgency episodes per day is 1 or over 5. other inclusion criteria as specified in the study protocol exclusion criteria: 1. patients with genuine stress incontinence 2. patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection 3. patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study 4. patients suffering from complications for which anticholinergics are contraindicated 5. other exclusion criteria as specified in the study protocol

Keywords: ono-8025, krp-197, overactive bladder, antimuscarinic